The Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies.

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Leadership Tempo pieno Onsite

Experience Required

7.0 - 10.0 Years

The Global Regulatory Affairs Lead is responsible for end-to-end product registrations and regulatory strategy across multiple geographies.

This role ensures that all Taevas products meet country-specific regulatory requirements and are approved for market entry in a timely and compliant manner.

Key Responsibilities

Global Product Registrations

Lead regulatory submissions across key markets (India, US, EU, UAE, LATAM, APAC, etc.).

Prepare and submit dossiers (CDSCO, US FDA, CE/MDR, MOHAP, PMDA, COFEPRIS, etc.).

Manage technical documentation (Technical File, STED, DMF, CER, etc.).

Track approvals, renewals, and post-market variations.

Regulatory Strategy





Define registration pathways for new products and markets.

Provide regulatory feasibility inputs during product selection / OEM onboarding.

Optimize timelines and cost for registrations globally.

Stakeholder & Agency Management

Liaise with Notified Bodies, regulatory consultants, labs, and local agents.

Coordinate with international partners for country-specific approvals.

Labeling & Compliance

Ensure compliance for labeling, IFUs, UDI, packaging requirements. xkiyazw

Align regulatory documentation with market-specific requirements.

Preferred Profile

6-12+ years in medical device regulatory affairs

Experience in multi-country registrations

Exposure to US FDA, CE/MDR, CDSCO

Strong documentation & coordination skills

Experience in a medical device manufacturing company (preferred)

Application Deadline

07/31/2026

📌 Manager – Global Regulatory Affairs (Bolzano Vicentino)
🏢 Altro
📍 Bolzano Vicentino